Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Recurrence

Esophageal Neoplasms

Disease Attributes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Nedaplatin

Tubulin Modulators

Antimitotic Agents

Patients after R0 surgery whose recurrence lesion larger than 5cm in diameter, or largest diameter was less than 5cm but with skip metastasis far from primary tumor or their time-to-recurrence longer than 16 months were assigned to involved field irradiation group. For lesions far from the thoracic stomach, the prescribed dose is 60Gy/2Gy/30f, and for lesions close to the thoracic stomach, the prescribed dose is 59.4-61.2Gy/1.8Gy/33-34f. Chest CT scan is planned at 50Gy. Radiation field should be modified according to the tumor response. Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks. PEG-rhG-CSF (3-6mg) should be given after 48 hours of chemotherapy.If patients received postoperative chemotherapy of paclitaxel and platinum and went through local-regional recurrence within six months, it is allowed to deliver chemotherapy regimens in the second line. Consolidate chemotherapy were adjusted to the patients after radiation therapy.

Patients after R1/R2 surgery or R0 surgery with the recurrence lesion whose diameter was less than 5cm without skip metastasis far from primary tumor and time-to-recurrence shorter than 16 months were assigned to elective field irradiation group. For lesions far from the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f with a simultaneously integrated boost up to 59.92-62.16Gy/2.14-2.22Gy/28f. For lesions close to the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f with a sequential boost of 10-12Gy/1.8-2Gy/5-7f. For patients whose planned thoracic stomach V50\>50%, the dose should be lowered to 45Gy/1.8Gy/25f. Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks. PEG-rhG-CSF should be given in need. If patients received postoperative chemotherapy of TP and went through local-regional recurrence within 6 months, chemotherapy regimens delivered in the second line. Consolidate chemotherapy were adjusted to the patients after radiation therapy.

Involved field irradiation; intensity-modulated radiation therapy

Involved field irradiation

Elective field irradiation; intensity-modulated radiation therapy

Elective field irradiation

Paclitaxel 135-150mg/m2, d1, every 3 weeks

for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;

Platinum

PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy

PEG-rhG-CSF

Zefen Xiao, MD

Lei Deng, MD

Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received radical surgery. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation. The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery.

Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received surgery as their first treatment. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation.

Retrospective data of 218 cases in our hospital indicated patients underwent salvage chemoradiation had significantly improved survival compared with chemotherapy, radiotherapy or best supportive care. For patients with locoregional recurrence, the 1-, 3-year overall survival (OS) rates were statistically higher in patients received salvage chemoradiation than radiotherapy (1-year OS, 70.0% vs. 55.2%, 3-year OS, 41.9% vs. 23.5%, p=0.045). Patients received chemotherapy had 1-year OS of 0%.

Data of 218 cases of our hospital indicated patients received radiation dose \> 54Gy had a significantly longer median overall survival time of 21.2 months compared with 11.3 months in patients had \<54Gy. The optimal radiation dose should be further investigated.

The recurrence pattern of patients with esophageal cancer after esophagectomy mainly consist of supraclavicular and mediastinal lymph nodes. For patients recurred after radical surgery, prophylactic irradiation to high-risk lymph node regions should be considered. The study use simultaneously integrated boost (SIB) intensity-modulated radiation therapy (IMRT) in this trial, which made different radiation dose to recurrent tumor and high-risk lymph node regions possible.

The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery. Patients were further assigned to receive elective field irradiation (ENI) or involved field irradiation (IFI) according to tumor size, tumor location and time-to-recurrence.

Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients

Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial

The First Affiliated Hospital with Nanjing Medical University

Tianjin Medical University Cancer Institute and Hospital

Anyang Tumor Hospital

Fujian Cancer Hospital

Peking University Cancer Hospital & Institute

Hebei Medical University Fourth Hospital

Chinese Academy of Medical Sciences

Professor

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Anti-Inflammatory Agents

Antirheumatic Agents

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Rituximab

Bleomycin

Vinblastine

Dacarbazine

Antineoplastic Agents, Immunological

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Rituximab plus ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) for 4 cycles

ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) for 4 cycles followed by involved field irradiation

I.V. infusion weekly x 6 weeks at a dose of 375 mg/m2

Radiation therapy, limited to initially involved nodal sites, will start within four weeks from the last cycle of ABVD chemotherapy and after complete restaging with TAC total-body and PET total-body. The planned total dose is 30,6 Gy.

Alessandro M Gianni, MD

Combined modality therapy has then emerged as the standard of care for limited-stage Hodgkin's lymphoma and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy that is devoid of alkylating agents and associated with a low potential for gonadal toxicity and leukemogenesis, is currently considered a gold standard. Nevertheless, the disadvantage to combine radiotherapy to ABVD is represented by late cardiovascular events (myocardial dysfunction and coronary or valvular disease), especially when the heart is within the radiation field; bleomycin pulmonary toxicity also is increased in conjunction with RT and secondary tumors, in particular in the RT fields. This study aims at treating patients with limited disease with multiagent chemotherapy alone, without irradiation, and using radiotherapy only for relapses.

Limited-stage Hodgkin lymphoma is a highly curable disease, with expected long-term disease-free and overall survival rates close to 90% and 95%, respectively. This success has come at a cost of long-term treatment-related toxicity, such that the patients who live beyond 10 to 15 years are more likely to die from late complications of treatment than from the disease itself. In the last decades efforts to improve long-term results have been made by developing curative strategies aimed to reduce toxicity while maintaining high cure rates. Based on the observation that systemic chemotherapy can control occult sites of the disease, thereby eliminating the requirement for staging laparotomy, in the last years the use of combined modalities that allowed a reduction of number of cycles of chemotherapy and of radiation field size and doses, thus reducing late toxicity was investigated in various clinical trials. Combined modality therapy has then emerged as the standard of care for limited-stage Hodgkin's lymphoma and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy that is devoid of alkylating agents and associated with a low potential for gonadal toxicity and leukemogenesis, is currently considered the gold standard. Nevertheless, optimal treatment is still a question of debate and current investigations are now taking into consideration to further reduce long-term toxicity. Actually two main options are available. The first option combines radiotherapy to ABVD chemotherapy, with the aim to maximize disease control. Using 4 cycles of ABVD followed by involved field radiotherapy at 36 Gy, Bonadonna and coworkers first documented a 94% freedom-from-progression and a 94% overall survival rate, respectively. The disadvantage with this approach is represented by late cardiovascular events (myocardial dysfunction and coronary or valvular disease), especially when the heart is within the radiation field; bleomycin pulmonary toxicity also is increased in conjunction with RT and secondary tumors, in particular in the RT fields. Whether these risks will be lower with fewer chemotherapy cycles, lower RT doses, or both has been studied in many clinical trials that have demonstrated that smaller radiation fields and lower doses are important, but a key unanswered question is whether RT can be eliminated completely in limited-stage patients. The second option therefore consists of chemotherapy with ABVD alone, with the aim to eliminate the late effects of radiotherapy. This approach have resulted in an absolute increase of the failure rate in the order of 8% (from approximately 4% up to 12%). However, the majority of relapsing patients achieves a durable disease control with a second-line radiation-containing combined approach, and shows an overall survival rate superimposable to that of patients receiving upfront combined strategy with chemo-radiotherapy. We thus designed a study aimed at treating patients with limited disease with multiagent chemotherapy alone, without irradiation, and using radiotherapy only for relapses. In fact, it has recently been reported that the addition of Rituximab (a monoclonal antibody directed against the CD20 B-cell antigens) to ABVD significantly increases the antilymphoma activity of ABVD alone in advanced-stage Hodgkin's lymphoma and in absence of added toxicity. In conclusion, rituximab-supplemented ABVD (R-ABVD) given to early-stage Hodgkin's lymphoma might represent a radiation-free regimen capable of increasing long-term disease control of ABVD alone, while avoiding the late effects of radiotherapy.

The primary objective of this study is to evaluate whether the R-ABVD therapy (ARM A) is not worse than the standard therapy of ABVD-RT (ARM B) in patients with limited Hodgkin's lymphoma. In this trial a maximum inferiority of 8% of the 3-year Failure Free Survival rate (FFS) in ARM A with respect to ARM B is considered acceptable to assess that ARM A is not worse than ARM B.

R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma

Phase III Study Comparing Rituximab-supplemented ABVD (R-ABVD) With ABVD Followed by Involved-field Radiotherapy (ABVD-RT) in Limited Stage (Stage I-IIA With no Areas of Bulk) Hodgkin's Lymphoma

Fondazione Michelangelo

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients	NCT03731442	Esophageal Canc...	Involved field ... Elective field ... Paclitaxel Platinum PEG-rhG-CSF	16 Years - 70 Years	ChineseAMS
R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma	NCT00992030	Hodgkin Lymphom...	Rituximab Involved field ...	18 Years -	Fondazione Michelangelo
R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma	NCT00992030	Hodgkin Lymphom...	Rituximab Involved field ...	18 Years -	Fondazione Michelangelo

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