Clinical trial · Observational
Late-term Effects of Hypofractionated Chest Wall and Regional Nodal Irradiation in Patients With Breast Cancer
Dept. of Radiation Oncology, PGIMER, Chandigarh
- 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)
Survival of breast cancer patients has improved with multimodality treatment. Hypofractionated radiotherapy (RT) is rapidly emerging as one of the options for breast cancer patients after breast conservation surgery (BCS) but data on postmastectomy radiation therapy (PMRT) with hypofractionation is lacking and there is always concern for the late effects of RT especially with regional nodal irradiation (RNI). The potential survival benefits of locoregional radiation needs to be balanced with late-term effects. There is a dearth of data on RNI with hypofractionation. Therefore, reporting late-term effects of radiation in these patients is of utmost importance, especially with hypofractionation. Very few patients were given PMRT or RNI in the START trials, so definitive conclusions about the safety of shorter fractionation RNI cannot be drawn from these studies.1-3 There are also studies from Canada and the US with similar dose fractionations in the PMRT setting with limited number of patients but without RNI.4,5 There is a world-wide need for data on PMRT and especially with RNI for patients with breast cancer with its late-term consequences. Because of this, many radiation oncology societies are hesitant in recommending hypofractionated RNI. It is also an area for potential research in breast cancer radiotherapy. We have published our clinical outcomes with 3 weeks of adjuvant local and RNI with hypofractionation in the past.6-10 In this study, we will report late-term effects of PMRT and RNI with this schedule in patients with stage II and III breast cancer from a single institute from India which is practicing hypofractionation since 1976.
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 |
|---|---|---|---|
| Late Effects of Hypofractionated Radiotherapy in Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Chest wall fibrosis ("change" is being assessed)
- timeFrame
- 5, 10 and 15 years
- description
- Late fibrosis was defined grade 1 as barely palpable firmness, grade 2 as definite increased firmness and grade 3 as marked firmness of the chest wall.
Secondary outcomes (4)
- measure
- Telengiectasia ("change" is being assessed for all outcomes)
- timeFrame
- 5, 10 and 15 years
- description
- Telangiectasia was defined grade 1 as \<1cm2, grade 2 as 1 cm2-4 cm2 and grade 3 as \>4 cm2 area of chest wall
- measure
- Lymphedema
- timeFrame
- 5, 10 and 15 years
- description
- Lymphedema was graded by measuring arm circumference 10cm above and below the medial epicondyle of humerus . For lymphedema and shoulder function, the treated side was compared with the untreated opposite side as a reference. Lymphedema was classified as none, mild, moderate and marked if there was no difference, 0.5-2cm, 2.1-3cm and \>3cm difference, respectively in the circumference of the affected and normal arm.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * invasive carcinoma of the breast, post mastectomy complete microscopic excision of primary tumour and stage II or III disease Exclusion Criteria: * breast conserving surgery, stage I or IV disease, past history of malignancy except (i) basal cell skin cancer or CIN cervix uteri or(ii) non- breast malignancy if treated with curative intent and at least 5 years disease-free or contralateral breast cancer, ductal carcinoma in situ (DCIS), bilateral breast cancer
References
Publications (0)
Data not yet available