Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193804
Status:
COMPLETED
Last Update Posted:
2019-09-16
First Post:
2005-09-13
Brief Title:
A Trial Comparing Intensity Modulated Radiation Therapy IMRT With Conventional Radiation Therapy in Stage IIB Carcinoma Cervix
Sponsor:
Tata Memorial Hospital
Organization:
Tata Memorial Hospital
Study Overview
Official Title:
A Phase II Randomized Trial Comparing Intensity Modulated Radiation Therapy IMRT With Conventional Radiation Therapy in Stage IIB Carcinoma Cervix
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study to evaluate the efficacy of Intensity Modulated Radiation Therapy IMRT as compared to Standard Conventional Radiotherapy Alone in the treatment of carcinoma cervix Concomitant Weekly Cisplatin chemotherapy will be given as a routine which is a standard of care today for early stage cervical cancers including stage IIB The benefits of using IMRT in reducing radiation-induced toxicity are well known Since this treatment modality has not yet been validated and studied in a randomized trial setting the present study is being undertaken The study arm of IMRT has the potential to reduce the toxicities by 15-20 but is associated with labor intense procedure requiring many hospital visits before actual start of treatment
Detailed Description:
Carcinoma Cervix is the commonest malignancy seen in Indian women and constitutes approximately 10 of all cancers at Tata Memorial Hospital 1 It is also the leading cause of cancer mortality in India Nearly 85 of the patients present with advanced stages FIGO Stage IIIII The main stay of treatment has traditionally been radical radiation therapy with 80-90 of patients requiring radiation in their lifetime and over decades the survival rates have achieved a plateau of 30 - 55 at 5 years
Radiation therapy is usually a combination of external beam and intracavitary brachytherapy External beam radiation includes irradiation of primary tumor and nodal areas of risk Higher Doses of external beam radiation is limited due to normal critical organs namely small bowel rectum and bladder A major concern with pelvic radiation is the considerable volume of both small bowel and rectum is included in the radiation treatment fields Unsurprisingly gastrointestinal radiation reactions include diarrhea while late sequelae include small bowel obstruction enteritis and diarrhea are common 2-4 The benefits of multiple fields high energy beams customized blocking and low fraction sizes are well known 4 Various methods have been used to reduce the small bowel complications Surgical methods include absorbable meshes 5 tissue expanders 6 and omentoplasty 7 However these approaches are not feasible in patients undergoing definitive radiation Apart from small bowel toxicity late rectal and bladder complications are also of a major concern The clinical manifestations vary from mild proctitis stricture bleeding ulcers and fistula formation to hemorrhagic cystitis requiring cystectomy Grade III radiation cystitis and proctitis reported are in the range of 3-15 with radiation alone
Moreover of late the pattern of practice is increasingly being emphasized on concomitant chemo radiation 89 The addition of chemotherapy though has no doubt improved the survivals but has also led to increase in normal tissue toxicities In the RTOG 90-01 and 92-10 there is alarming increase in the gastro intestinal 35 grade III and grade IV and genitourinary 9 grade III and grade IV
The changes in the treatment policies and the toxicities associated with wide pelvic radiation therapy demand for better normal tissue sparing radiation techniques or radioprotective agents Three Dimensional Conformal Radiation Therapy 3D-CRT to some extent has successfully achieved some normal tissue sparing Intensity-modulated radiotherapy IMRT is an important recent advance in radiation therapy and is at the forefront of Translational Research With 3DCRT the radiation intensity is generally uniform within the radiation portal whereas in IMRT the dose intensity within the portal varies with the use of beamlets thereby allows a higher degree of conformation to the tumor than previously possible and allows concave isodose profiles to be generated
Over last 10 years IMRT has been successfully used in the treatment of prostate head and neck and brain tumors IMRT in pelvic radiation has the potential to reduce the dose as well as the volume of rectum bladder and small bowel irradiated significantly and thereby translating into a decrease in the incidence and severity of acute and late gastro-intestinal and genito-urinary toxicities Several dosimetric studies have been reported to confirm the role of IMRT in reducing toxicities with pelvic radiation therapy 1011 These dosimetric studies have reported that the volume of small bowel irradiated to the prescription dose by a factor of 2 compared with conventional radiation The average volume of bladder and rectum irradiated is also reduced by 23 12 In our series of 10 patients treated IMRT in pelvic radiation therapy apart from reducing the hot spot volumes and better conformity index to the target volume also significantly reduces the volumes of high dose regions in small bowel region by 17 rectum by 50-60 and bladder by 40-50 unpublished data In another series of early report on outcome of 40 patients treated with IMRT to whole pelvis Arno el al have demonstrated that there is a significant reduction in acute radiation related toxicities but it is too early to comment on late sequelae since the follow-up is short and has concluded that this novel approach definitely needs to be validated in a trial setting 13
Radiation therapy is usually a combination of external beam and intracavitary brachytherapy External beam radiation includes irradiation of primary tumor and nodal areas of risk Higher Doses of external beam radiation is limited due to normal critical organs namely small bowel rectum and bladder A major concern with pelvic radiation is the considerable volume of both small bowel and rectum is included in the radiation treatment fields Unsurprisingly gastrointestinal radiation reactions include diarrhea while late sequelae include small bowel obstruction enteritis and diarrhea are common 2-4 The benefits of multiple fields high energy beams customized blocking and low fraction sizes are well known 4 Various methods have been used to reduce the small bowel complications Surgical methods include absorbable meshes 5 tissue expanders 6 and omentoplasty 7 However these approaches are not feasible in patients undergoing definitive radiation Apart from small bowel toxicity late rectal and bladder complications are also of a major concern The clinical manifestations vary from mild proctitis stricture bleeding ulcers and fistula formation to hemorrhagic cystitis requiring cystectomy Grade III radiation cystitis and proctitis reported are in the range of 3-15 with radiation alone
Moreover of late the pattern of practice is increasingly being emphasized on concomitant chemo radiation 89 The addition of chemotherapy though has no doubt improved the survivals but has also led to increase in normal tissue toxicities In the RTOG 90-01 and 92-10 there is alarming increase in the gastro intestinal 35 grade III and grade IV and genitourinary 9 grade III and grade IV
The changes in the treatment policies and the toxicities associated with wide pelvic radiation therapy demand for better normal tissue sparing radiation techniques or radioprotective agents Three Dimensional Conformal Radiation Therapy 3D-CRT to some extent has successfully achieved some normal tissue sparing Intensity-modulated radiotherapy IMRT is an important recent advance in radiation therapy and is at the forefront of Translational Research With 3DCRT the radiation intensity is generally uniform within the radiation portal whereas in IMRT the dose intensity within the portal varies with the use of beamlets thereby allows a higher degree of conformation to the tumor than previously possible and allows concave isodose profiles to be generated
Over last 10 years IMRT has been successfully used in the treatment of prostate head and neck and brain tumors IMRT in pelvic radiation has the potential to reduce the dose as well as the volume of rectum bladder and small bowel irradiated significantly and thereby translating into a decrease in the incidence and severity of acute and late gastro-intestinal and genito-urinary toxicities Several dosimetric studies have been reported to confirm the role of IMRT in reducing toxicities with pelvic radiation therapy 1011 These dosimetric studies have reported that the volume of small bowel irradiated to the prescription dose by a factor of 2 compared with conventional radiation The average volume of bladder and rectum irradiated is also reduced by 23 12 In our series of 10 patients treated IMRT in pelvic radiation therapy apart from reducing the hot spot volumes and better conformity index to the target volume also significantly reduces the volumes of high dose regions in small bowel region by 17 rectum by 50-60 and bladder by 40-50 unpublished data In another series of early report on outcome of 40 patients treated with IMRT to whole pelvis Arno el al have demonstrated that there is a significant reduction in acute radiation related toxicities but it is too early to comment on late sequelae since the follow-up is short and has concluded that this novel approach definitely needs to be validated in a trial setting 13
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None