Clinical trial · Observational
A Trial Comparing Intensity Modulated Radiation Therapy (IMRT) With Conventional Radiation Therapy in Stage IIB Carcinoma Cervix
A Phase II Randomized Trial Comparing Intensity Modulated Radiation Therapy (IMRT) With Conventional Radiation Therapy in Stage IIB Carcinoma Cervix
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Cervix | Malignant Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 2
- description
- Patients with histologically proven, cervical cancer FIGO Stage IIB eligible will be invited for the study. The patients will recieve either 3D conformal radiation or IMRT external radiation with concomitant cisplatin chemotherapy followed by brachytherapy.
- interventionNames
- Radiation: IMRT
Primary outcomes (1)
- measure
- To compare the normal tissue toxicities (Acute & Late) of standard radiation therapy with IMRT
- timeFrame
- 2017
Secondary outcomes (3)
- measure
- To compare the disease free survivals
- timeFrame
- 2017
- measure
- To compare the quality of life in both the groups
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven squamous carcinoma or adenocarcinoma of cervix * Performance index WHO grade 0 or 1 * Patients below 65 years of age * FIGO Stage IIB * Normal ECG and Cardiovascular system * Normal hematological parameters * Normal renal and liver function tests Exclusion Criteria: * Co-morbid conditions like medical renal disease * Medical or Psychological condition that would preclude treatment * H/o Previous treatment / Pregnancy * Patient unreliable for treatment completion and follow-up.
References
Publications (0)
Data not yet available